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RegisterICH M13A complex study designs missing data and data excluded [Regulatives / Guidelines]
ICH M13A Q&A 2.9: When is it appropriate to remove data from statistical analysis for BE assessment?
I have 2 questions:
1. For 4*4 William's design, if the subject only completes one period, should it be excluded from BE evaluations? How many periods must each subject complete to include the data for BE evaluating?
2. For PK parameter analysis, can at least one period data to be included in PK parameter analysis?
Edit: Please follow the Forum’s Policy. Q&A document linked. [Helmut]
In a 2-way crossover design, if data from one period are excluded, the subject should not be included in the statistical analysis. In more complex study designs, removal of subject data from only one period may not result in the complete removal of the subject from the statistical analysis.
I have 2 questions:
1. For 4*4 William's design, if the subject only completes one period, should it be excluded from BE evaluations? How many periods must each subject complete to include the data for BE evaluating?
2. For PK parameter analysis, can at least one period data to be included in PK parameter analysis?
Edit: Please follow the Forum’s Policy. Q&A document linked. [Helmut]
Complete thread:
- ICH M13A complex study designs missing data and data excludedkimhuang 2025-03-04 08:12 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M13A: Two-at-a-Time Helmut 2025-03-04 09:24
- ICH M13A: Two-at-a-Time kimhuang 2025-03-07 00:46
- ICH M13A: Descriptive statistics Helmut 2025-03-07 08:45
- ICH M13A: Descriptive statistics kimhuang 2025-03-08 05:55
- ICH M13A: Descriptive statistics Helmut 2025-03-07 08:45
- ICH M13A: Two-at-a-Time kimhuang 2025-03-07 00:46
- ICH M13A: Two-at-a-Time Helmut 2025-03-04 09:24
Ing. Helmut Schütz